摘要
目的:评价国产洛美利嗪胶囊治疗偏头痛的疗效及安全性。方法:采用多中心、随机、双盲、氟桂利嗪阳性药平行对照研究,为期56 d,洛美利嗪组(试验组)服用洛美利嗪(5 mg,bid),共105例,氟桂利嗪组 (对照组)服用氟桂利嗪(5 mg,qn),共99例。结果:治疗28,56 d,试验组病人在头痛综合评分、病人自觉头痛评分,综合临床疗效自身前后比较差异均有统计学意义(P<0．01),治疗28 d时试验组有效率(79．1％)略高于对照组(74％),试验组在短时间内疗效更明显;不良反应轻微,试验组发生率(5．6％)略低于对照组(8．8％), 均不影响继续用药。结论:洛美利嗪是一种不良反应较少、安全有效治疗偏头痛发作的药物。
AIM：To evaluate the efficacy and safety of domestic lomerizine capsule in treating migraine. METHODS： Two hundred and four patients were divided into lomerizine group（experimental group, 105 patients） and flunarizine group （control group, 99 patients）,with treatment of lomerizine or flunarizine respectively,which was carried out through randomized,double blind, parallel controlled study with flunarizine as the positive control medicine.The total course was 56 d. The efficacy was calculated according to the changes of headache sores.RESULTS：The patients of the experimental group were significantly improved in cephalalgia synthetic score, self-feeling cephalalgia score and synthetic clinical effect （P 〈 0.01 ） after treatment of lomerizine in comparing with untreated ones. There was no significant difference between two groups. The total effective rates was 79.1% for experimental group and 74 % for positive control The incidences of adverse Domestic lomerizine is an group in 28 d,a little higher than that of the control group. reactions were 5.6 % and 8.8 % respectively,without serious ones. CONCLUSION： effective and safe agent for migraine.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2006年第3期166-169,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
偏头痛
多中心研究
双盲法
随机对照试验
洛美利嗪
氟桂利嗪
migraine
multicenter studies
double-blind method
randomized controlled trials
lomerizine
flunarizine
